Sympathetic-Somatomotor Coupling in Human Spinal Cord Injury

NCT02115685 | Completed

• 1 other identifier: R01NS079751
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Significance: The long term objective of this study is to improve physical therapy and fitness programs in people with spinal cord injury. The results of the study will demonstrate the importance of matching blood flow to a muscle with exercise of that same muscle. Scientific Objective: The objective of the study is to measure how the body regulates bloodflow to a muscle during exercise. We intend to study these effects by triggering blood flow changes during movement, and measuring bloodflow changes during exercise in people with spinal cord injury. We will also look at the long term effects of different exercise programs on bloodflow during exercise. Study Populations: This study will involve people with partial spinal cord injury and age and sex matched controls without injury. Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) upper body ergometry, 2) treadmill training with exertion level matched to the upper body ergometry and 3) treadmill training with heart rate matched to an initial test of upper body ergometry.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; sympathetic nervous system; locomotor training; exercise

Outcome Measures

Primary Outcomes (1)

• Arterial blood flow

  Subject will be tested with doppler ultrasonography immediately pre and post sympathetic stressor. Testing sessions will take anywhere between 3-6 hours.

  6 hours

Secondary Outcomes (4)

• Graded Treadmill Exercise Test

  15 months

• Heart rate

  15 months

• Knee torque

  8 hours

• Tendon tap reflexes

  8 hours

Study Arms (2)

One day testing

NO INTERVENTION

Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury.

Effects of long term training

EXPERIMENTAL

Aim 3 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) treadmill training at high intensity as defined by 70-80% of HRR or 15-17 RPE 2) treadmill training at low intensity as defined by 30-40% of HRR or \<13 RPE

Other: Treadmill Training

Interventions

Treadmill Training OTHER

Subjects will be randomized to a high intensity and low intensity group. The high intensity group will train at 70-80% of their HRR and the low intensity group will train at 30-40% of their HRR.

Effects of long term training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• incomplete SCI
• subjects will be over age 18
• to fit in the apparatus and to assure a mature gait pattern
• at least 6 months post injury, and medically stable with an incomplete lesion between levels T1-T10
• lower extremity motor score of 10 or greater
• presence of intact stretch reflexes, detected clinically
• no previous history or evidence of peripheral nerve damage in the lower extremities
• Subjects must be able to step on a treadmill with no more than 40% body weight support.
• Healthy controls will be age and sex matched to the subjects with spinal cord injury.

You may not qualify if:

• unhealed decubiti,
• bladder or other infection
• severe contracture or osteoporosis
• heterotopic ossification
• cardiac arrhythmia
• inability to give informed consent
• an episode of autonomic dysreflexia in the past year
• use of spasticity or cardiovascular medications (e.g. baclofen)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Marquette University: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.

  PMID: 32476619 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Brian D Schmidt, MD

  Marquette University

  PRINCIPAL INVESTIGATOR

• George Hornby, PT, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-04

Locations

US (1)